Overview
Sponsor-declared trial summary
Menopause, sleep disorders in the postmenopausal period
Demonstration that 12-week supplementation with 20 mg DHEA and 2 mg sustained-release melatonin improves sleep quality and reduces daytime sleepiness. Demonstration that supplementation with 20 mg DHEA and 2 mg sustained-release melatonin improves mood and reduces the severity of vasomotor symptoms associated with meno…
Key facts
- Sponsor
- The Pharmaceutical Company LEK-AM Sp. Zoo., Przedsiebiorstwo Farmaceutyczne Lek-Am Sp. z o.o.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Female
- Therapeutic area
- Diseases [C] - Female Urogenital Diseases and Pregnancy Complications [C13], Health Care [N] - Health Care Quality, Access, and Evaluation [N05]
- Trial duration
- 30 Nov 2024 → ongoing
- Decision date (initial)
- 2025-01-30
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-520234-30-00
- EudraCT number
- 2022-004160-16
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Diagnosis, Therapy, Safety, Efficacy, Prophylaxis
Demonstration that 12-week supplementation with 20 mg DHEA and 2 mg
sustained-release melatonin improves sleep quality and reduces daytime sleepiness.
Demonstration that supplementation with 20 mg DHEA and 2 mg sustained-release melatonin
improves mood and reduces the severity of vasomotor symptoms associated with menopause.
Secondary objectives 1
- Demonstration that DHEA supplementation at a dose of 20 mg and 2 mg of sustained-release melatonin affects the concentration of DHEAS and estradiol.
Conditions and MedDRA coding
Menopause, sleep disorders in the postmenopausal period
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | LLT | 10040999 | Sleep disturbed | 10037175 |
| 21.1 | LLT | 10050903 | Postmenopausal symptoms | 10038604 |
| 20.0 | PT | 10027308 | Menopause | 100000004869 |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 1
- woman, BMI 20.0-29.9 kg / m2, the time since the last menstruation for at least 12 months, stable body weight during the last 6 months, FSH concentration 35-135 mIU / ml and estradiol 5-55 pg / ml, total testosterone concentration 0.084 - 0.481 ng / ml, score on the Athens Insomnia Scale> 6 points, Beck Depression Score 11–27 points, Kupperman Scale score 17-30 points, Epworth scale score, no use of menopausal replacement therapy for at least 6 months, The ability to understand audit procedures and provide written informed consent.
Exclusion criteria 1
- Current use of menopausal replacement therapy, The use of phytoestrogens, The use of psychotropic drugs, Taking sleeping pills, - Use of oral or intravenous glucocorticosteroids, Vaginal application of DHEA (Prasteron), Current or history of oncological disease, Decompensated thyroid disease or other endocrine disease such as Cushing's syndrome, Diagnosed obstructive sleep apnea, Uncontrolled cardiovascular diseases (hypertension, coronary artery disease, heart failure), Osteoarthritis with significant pain ailments with the use of steroid therapy, Rheumatoid arthritis and other rheumatological diseases with the use of steroids, A disease of the nervous system that may affect sleep disturbances, History of mental illness (except postmenopausal depression), The patient's lack of cooperation.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- The primary endpoints of this study are to evaluate the effects of 12 weeks of DHEA 20 mg and 2 mg sustained-release melatonin on sleep quality in postmenopausal women and on mood and reduction of menopausal vasomotor symptoms.
Secondary endpoints 1
- Assessment of the effect of 12-week administration of DHEA in a dose of 20 mg and 2 mg of sustained-release melatonin on the serum concentration of DHEAS, estradiol, LH and SHBG.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 2
Senaxa PR, 2 mg, tabletki o przedłużonym uwalnianiu
PRD10365473 · Product
- Active substance
- Melatonin
- Pharmaceutical form
- PROLONGED-RELEASE TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 2 mg milligram(s)
- Max total dose
- 2 mg milligram(s)
- Max treatment duration
- 12 Week(s)
- Authorisation status
- Authorised
- ATC code
- N05CH01 — -
- Marketing authorisation
- 27734
- MA holder
- PRZEDSIĘBIORSTWO FARMACEUTYCZNE LEK-AM SP. ZO.O.
- MA country
- Poland
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
PRD333221 · Product
- Active substance
- Prasterone
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 20 mg milligram(s)
- Max total dose
- 20 mg milligram(s)
- Max treatment duration
- 12 Week(s)
- Authorisation status
- Authorised
- ATC code
- A14AA07 — PRASTERONE
- Marketing authorisation
- 9580
- MA holder
- PRZEDSIĘBIORSTWO FARMACEUTYCZNE LEK-AM SP. Z O.O.
- MA country
- Poland
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
The Pharmaceutical Company LEK-AM Sp. Zoo.
- Sponsor organisation
- The Pharmaceutical Company LEK-AM Sp. Zoo.
- Address
- ul. Ostrzykowizna 14A
- City
- Zakroczym
- Postcode
- 05-170
- Country
- Poland
Scientific contact point
- Organisation
- The Pharmaceutical Company LEK-AM Sp. Zoo.
- Contact name
- The Pharmaceutical Company LEK-AM Sp. Zoo.
Public contact point
- Organisation
- The Pharmaceutical Company LEK-AM Sp. Zoo.
- Contact name
- Ewa Malecka
Przedsiebiorstwo Farmaceutyczne Lek-Am Sp. z o.o.
- Sponsor organisation
- Przedsiebiorstwo Farmaceutyczne Lek-Am Sp. z o.o.
- Address
- Ul. Ostrzykowizna 14 A
- City
- Zakroczym
- Postcode
- 05-170
- Country
- Poland
Scientific contact point
- Organisation
- Przedsiebiorstwo Farmaceutyczne Lek-Am Sp. z o.o.
- Contact name
- Ewa Malecka
Public contact point
- Organisation
- Przedsiebiorstwo Farmaceutyczne Lek-Am Sp. z o.o.
- Contact name
- Ewa Malecka
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Poland | Ongoing, recruiting | 100 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Poland | 2024-11-30 | 2024-11-30 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 6 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol 2024-520234-30-00 | 2 |
| Recruitment arrangements (for publication) | K2_Recruitment material_leaflet | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF adults | 2 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Biosteron | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Senaxa PR | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis PL 2024-520234-30-00 | 2 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-01-02 | Poland | Acceptable 2025-01-29
|
2025-01-30 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-04-14 | Poland | Acceptable 2025-05-13
|
2025-05-13 |